Xanomeline impurity 47 CAS CATO-C4X-330147

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Xanomeline impurity 47.

CATO supplies Xanomeline impurity 47 (CAS CATO-C4X-330147), a pharmacopoeial impurity reference standard (molecular formula C14H20N3OSI, MW 405.29 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C14H20N3OSI, Xanomeline impurity 47 contains a nitrogen-containing heterocyclic scaffold, an amide group, sulfur-containing functionality, a hydroxyl group, an ether linkage, iodine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 405.29 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

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